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Trial record 1 of 1 for:    NCT00481728
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Evaluation of the Link Between Bladder Sensation and Changes in Skin Electrical Conductance and Heart Rate.

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ClinicalTrials.gov Identifier: NCT00481728
Recruitment Status : Completed
First Posted : June 4, 2007
Last Update Posted : May 28, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE June 1, 2007
First Posted Date  ICMJE June 4, 2007
Last Update Posted Date May 28, 2009
Study Start Date  ICMJE June 2007
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2009)
Heart rate variability evoked by filling cystometry and intravesical neurostimulation and sympathetic skin response evoked by intravesical neurostimulation in healthy volunteers and OAB patients
Original Primary Outcome Measures  ICMJE
 (submitted: June 1, 2007)
To evaluate the reproducibility and sensitivity to drug induced changes in heart rate variability and sympathetic skin response evoked by filling cystometry and intravesical neurostimulation in healthy volunteers and OAB patients
Change History Complete list of historical versions of study NCT00481728 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2008)
  • To investigate the correlation between the changes in heart rate variability and sympathetic skin response evoked by filling cystometry and intravesical neurostimulation in OAB patients. [ Time Frame: duration of study ]
  • To determine whether there is a difference in the stimulus response relationship for the evoked changes in HRV and SSR between healthy volunteers and OAB patients. [ Time Frame: duration of study ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2007)
  • To investigate the correlation between the changes in heart rate variability and sympathetic skin response evoked by filling cystometry and intravesical neurostimulation in OAB patients.
  • To determine whether there is a difference in the stimulus response relationship for the evoked changes in HRV and SSR between healthy volunteers and OAB patients
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Link Between Bladder Sensation and Changes in Skin Electrical Conductance and Heart Rate.
Official Title  ICMJE Evaluation of Sympathetic Skin Responses and Heart Rate Variability as Objective Measures of Bladder Sensation - a Double Blind Third Party Open Placebo Controlled Randomised Study Using a Single Dose of Tolterodine in Patients With Idiopathic Overactive Bladder and Healthy Volunteers
Brief Summary Measuring sympathetic skin response or heart rate variability can provide an objective biomarker of bladder sensation and its modulation by drug with potential to treat overactive bladder.
Detailed Description Evaluation of the link between bladder sensation and changes in skin electrical conductance and heart rate.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Overactive Bladder
Intervention  ICMJE
  • Drug: Tolterodine
    Single dose per patient as determined by protocol.
  • Procedure: Filling cystometry
    This is a procedure.
  • Procedure: Intravesical neurostimulation
    This is a procedure.
Study Arms  ICMJE Experimental: Tolterodine
Interventions:
  • Drug: Tolterodine
  • Procedure: Filling cystometry
  • Procedure: Intravesical neurostimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 1, 2007)
28
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female, healthy volunteers or OAB patients 18-65 years old, non pregnant and non lactating

Exclusion Criteria:

  • History of lower urinary tract pathology
  • Excessive alcohol and tobacco consumption
  • Treatment with investigational drug in the last 30 days
  • Abnormal ECG trace
  • Conditions that would contraindicate the use of tolterodine or any other anti muscarinic agent
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00481728
Other Study ID Numbers  ICMJE A6121189
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP